Medtronic SCBA Instructions for Use

Sonicision™
Reusable Battery Pack
SCBA
SCBA Compatible with:
SCDA13 SCD7A48
SCD7A13 SCGAA
SCDA26 SCG7AA
SCDA39 CBCA
SCD7A39 SCBIGA
SCDA48
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Instructions for Use
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Sonicision™
SCBA
See Sonicision™ reusable battery pack product label for battery rating information.
Reusable Battery Pack
Indications for Use
The Sonicision™ reusable battery pack is a non-sterile, rechargeable, lithium-ion battery that provides power to compatible surgical devices. For full device indications for use, reference the indications for use statements of the compatible devices.
Not made with natural rubber latex
Figure 1: Sonicision™ reusable battery pack
A full list of symbols can be found in the system user’s guide that is provided with the reusable generator.
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Warning
Safe use of the battery pack requires the user to read, understand, and follow the accompanying instructions.
Refer to the system user’s guide that is provided with the reusable generator for specific indications, contraindications, warnings, cautions, residual risks, and operating instructions.
Do not immerse the battery pack.
Do not disassemble or modify the battery pack.
Inspect the battery pack for damage before use. Do not use a damaged battery pack.
Warning
The battery pack is non-sterile and cannot be sterilized. The battery pack will be damaged if sterilization is attempted.
Do not rinse the battery pack under running water or submerge the battery pack in water.
Do not use instrument lubricant on the battery pack.
Caution
Use of a battery pack that is not fully charged can result in a procedural delay.
The battery pack should be cleaned and disinfected after each use and before charging. Clean and disinfect the battery pack as instructed.
Note: Battery packs are shipped with a low state of charge and must be charged before use. Note: The battery pack is designed to be used up to 200 times, after which the battery pack is no longer usable and must be replaced.
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Note: Instructions provided in this document
are limited to the charging, cleaning, and disinfection of the Sonicision™ reusable battery pack. Refer to the system user’s guide that is provided with the reusable generator for complete information and important warnings and cautions related to the use of the battery pack. Note: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and necessary regulatory authority (if European Union, the competent authority of the Member State) in which the user and/or patient is established.
Cleaning and Disinfecting the Battery Pack
Note: Do not expose the battery pack connector to excessive moisture, conductive materials, or contaminants.
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Cleaning the Battery Pack
1. Moisten a lint-free cloth with a disinfectant
solution or use a disinfectant wipe.
Use one of the following disinfectants:
• Ethyl alcohol or isopropyl alcohol (70%)
• Hydrogen peroxide wipe (for example, Oxivir™* wipe)
2. Using a clean disinfectant wipe, wipe all
external surfaces of the battery pack until visually clean. Ensure the surface remains thoroughly wet by continuously wiping for the contact time recommended per the manufacturer's instructions.
• If using 70% ethyl alcohol or isopropyl alcohol, ensure a contact time of 1 minute.
• Pay special attention to the battery pack handle.
• Avoid contact with the battery pack connector.
• Use additional wipes if needed.
3. Use a lint-free cloth to dry all exposed
surfaces of the battery pack, taking care to avoid damage to the electrical contacts.
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4. Visually inspect the battery pack. If it is not
clean, repeat cleaning steps above.
Disinfecting the Battery Pack
1. Moisten a lint-free cloth with a disinfectant
solution or use a disinfectant wipe.
Use one of the following disinfectants:
• Ethyl alcohol or isopropyl alcohol (70%)
• Hydrogen peroxide wipe (for example, Oxivir™* wipe)
2. Using a clean disinfectant wipe, wipe all
external surfaces of the battery pack. Ensure the surface remains thoroughly wet by continuously wiping for the contact time recommended per the manufacturer's instructions.
• If using 70% ethyl alcohol or isopropyl alcohol, ensure a contact time of 1 minute.
• Pay special attention to the battery pack handle.
• Avoid contact with the battery pack connector.
• Use additional wipes if needed.
3. Use a lint-free cloth to dry all exposed
surfaces of the battery pack, taking care to avoid damage to the electrical contacts.
Charging the Battery Pack
1. To set up the battery charger, refer to the
system user’s guide that is provided with the reusable generator or the Sonicision™ battery charger instructions for use.
2. Place the battery pack into a charging bay
and ensure the battery pack is fully seated. The charging cycle will start automatically when the battery pack is inserted correctly into the battery charger (Figure 2: Place the battery pack into a charging bay).
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Figure 2: Place the battery pack into a charging bay
3. Note the display for the battery pack status.
Refer to the system user’s guide that is provided with the reusable generator or the Sonicision™ battery charger instructions for use for charging indication.
4. To remove a battery pack from a battery
charger bay, pull the battery pack straight up.
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Battery Pack Storage
The service life of the battery pack is monitored by the battery charger. Store the battery pack in the battery charger between uses. If the battery pack is stored off of the charger, the battery pack should be returned to the charger before use to verify functionality, state of charge, and to recharge as necessary. Refer to the system user’s guide that is provided with the reusable generator for environmental parameters.
Within the U.S. and Canada
Covidien has provided funding to support the recycling of Sonicision™ reusable lithium-ion batteries. Visit www.call2recycle.org for more information and to receive a prepaid collection kit.
Battery Pack Disposal
Discard or recycle the battery pack as required by local, state, and government regulations.
Covidien is committed to a healthy world and recommends that Sonicision™ reusable lithium-ion batteries be recycled following decontamination.
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Outside the U.S. and Canada
Covidien recommends that Sonicision™ reusable lithium-ion batteries be recycled in accordance with your local laws, rules, and national regulations.
More Information
Refer to the system user’s guide that is provided with the reusable generator for information regarding the following elements:
• Clinical benefits
• Troubleshooting
• Technical specification
ÑPT00148839/Ó
PT00148839
Single use
Consult
Instructions
for Use
Do not
resterilize
Caution
Part No. PT00148839
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company. May be covered by U.S. Patents: www.covidien.com/patents
© 2020 Covidien..
Manufactured for Covidien llc,
15 Hampshire Street, Mansfield, MA 02048 USA.
Made in USA (from US and foreign materials).
www.covidien.com REV 07/2021
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